By Sabela Ojea
Shares of DBV Technologies surged after it received positive regulatory updates in the U.S. and Europe for its Viaskin Peanut allergy patch.
The stock was up 47% to $1.03 in post-market trading on Tuesday. The stock has fallen 26% in the past three months, and 61% this year.
The clinical-stage biopharmaceutical company said it has agreed to guidance provided by the Food and Drug Administration on a pathway under the accelerated approval program for the Viaskin Peanut patch in toddlers ages 1 to 3 years old.
DBV said it intends to formalize the accelerated approval guidance by submitting a meeting request. Additionally, the company said it expects the confirmatory study to be initiated by the time of the Biologics License Applications submission, which would run in parallel to commercialization in the U.S. if the patch is approved.
The company also said it received scientific advice from the European Medicines Agency on an indication for children 1 to 7 years old for the peanut allergy treatment.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
October 22, 2024 17:22 ET (21:22 GMT)
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